Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study

Relapsing Multiple Sclerosis Clinical Trial

— TRIMS A  

Official title:

Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006941
• Other study ID #: Rigshospitalet, DMSC
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2009
• Last updated: November 9, 2011
• Start date: May 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The hypothesis of this study is that treatment with Trichuris suis ova will be safe and effective as an oral treatment of patients with relapsing multiple sclerosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

• age between 19 and 55 years

• relapsing course of multiple sclerosis (relapsing-remitting or secondary progressive MS with relapses

• duration of the disease of at least 1 year

• no disease modifying therapy or unchanged immunomodulatory therapy for the last 3 months

• at least 2 documented relapses during the last 24 months with the last relapse within the last 12 months

Exclusion Criteria:

• pregnancy or period of breastfeeding or missing adequate contraceptive protection for female premenopausal patients

• relapse in the last month prior enrolment

• treatment with steroids in the last 30 days

• previous treatment with mitoxantroneduring the last year

• previous treatment with cyclophosphamide or other intensive immunosuppression, total irradiation

• treatment with glatiramer acetate, azathioprine, IVIG or any other immunosuppressive or immunomodulatory drug apart from interferon-beta in the 6 months prior to enrolment

• cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, instable or advanced ischemic heart disease (CCS III or IV), malignant hypertension

• diabetes mellitus and other autoimmune diseases

• history of renal insufficiency

• stay in tropical areas during the last 3 months

• eosinophilia in the blood (> 0,45 billion/l)

• concurrent systemic infections

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• Trichuris suis ova
2500 ova per dose, orally, every second week, during 12 weeks

Locations

Country	Name	City	State
Denmark	Danish Multiple Sclerosis Center, Rigshospitalet	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen University Hospital, Hvidovre, OvaMed GmbH, Statens Serum Institut, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI activity judged by the number of new or enlarging T2 lesions, number of Gd enhancing lesions and volume of T2 lesions		every 3. week. 3 MRI before treatment and 4 MRI during and after treatment	Yes